Ultrasound-CT Fusion System for Interventional Radiology Procedures
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|ClinicalTrials.gov Identifier: NCT03226535|
Recruitment Status : Unknown
Verified July 2017 by Clear Guide Medical.
Recruitment status was: Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|CT Guided Biopsy CT Guided Drain Placement Within the Abdomen or Pelvis CT Guided Injection of Muscle or Nerve Within the Pelvis||Device: Ultrasound-CT Fusion||Not Applicable|
A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:
- 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
- Proper informed consent will be obtained
- Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
- The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
- If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
Once the needle is at the target, a confirmatory CT will be performed.
- If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
- If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ultrasound-CT Fusion System for Interventional Radiology Procedures|
|Actual Study Start Date :||June 22, 2017|
|Estimated Primary Completion Date :||June 22, 2018|
|Estimated Study Completion Date :||June 22, 2018|
Experimental: Ultrasound-CT Fusion Guidance
The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.
Device: Ultrasound-CT Fusion
The Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure.
Other Name: Clear Guide SCENERGY
No Intervention: CT Guidance
The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement.
- Number of CT scans or CT fluoroscopic images [ Time Frame: Immediately following intervention (within 2 hours) ]
- Total procedure time [ Time Frame: Immediately following intervention (within 2 hours) ]Time from the first CT scan until the needle is at the target
- Time to target [ Time Frame: Immediately following intervention (within 2 hours) ]Time from needle entering the skin until the needle is at the target
- Success of needle placement [ Time Frame: Immediately following intervention (within 2 hours) ]A confirmatory CT will be performed to check if the needle reached the target
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226535
|Contact: Brian Holly, MDfirstname.lastname@example.org|
|Contact: Taylor Dunklin, DAemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Brian Holly, MD 410-614-1622 firstname.lastname@example.org|
|Contact: Taylor Dunklin, DA 410-502-5118 email@example.com|
|Sub-Investigator: Douglas Yim, MD|
|Sub-Investigator: Clifford Weiss, MD|
|Principal Investigator: Brian Holly, MD|
|Sub-Investigator: Taylor Dunklin, DA|
|Sub-Investigator: Beatriz Kohler, RN, MBA, MPH|
|Principal Investigator:||Brian Holly, MD||Johns Hopkins University|